A QUALITY IMPROVEMENT TOOL AUDITING A QUALITY IMPROVEMENT TOOL NOVEMBER 18 ,2015 Joel Schwartzman Retired biguy25103@aol.com

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Audit Purpose The purpose of quality auditing is to examine the effectiveness of management directed control programs. The philosophy of quality assurance programs is based on prevention rather than detection of problems.

Audit Scope The Client determines the audit scope The Client may be, for example, the purchasing director, the research manager, the quality manager or the FDA District Director.

Audit objectives can be based on: Management priorities or system requirements Statutory, regulatory and contractual requirements A need for provider evaluation Risks to the organization Whatever the boss dictates

AUDITING MISTAKES - Auditing with the “gotcha” attitude Finding faults and not facts Not recognizing that the audit is people focused Not properly defining the purpose and scope Not using a quality audit checklist Not issuing corrective action Not conducting follow-up on the corrective action Not using a team approach in reviewing corrective actions

AUDITS CONSIST OF Interviews Data Review

Audit Preparation Learn about the provider Talk to people who deal with the provider Review complaints Review receiving reports Review contract Review audit standard- GMP, ISO Determine the audit focus

WHAT PERSONALITY TYPES AUDITORS WHAT PERSONALITY TYPES ARE AUDITORS?

Who to Audit QC Lab/Inspection/ Engineering Purchasing Production operators Receiving/Shipping Calibration Lab Document Control R&D/ Engineering Management

Interviewing Techniques Open ended questions Probing Silence Pauses Paraphrasing

DATA REVIEW Calibration Records Training CAPA Document Control Design Control Purchasing procedures Complaints Internal audits Receipt records Batch Records

WHAT TO ASK Each area has specific questions that need to be addressed

TOP MANAGEMENT How does management show commitment to quality Is there a current organization chart How are quality objectives established at various levels How are objectives measured and communicated

QUESTIONS CALIBRATION Is there an effective plan Are there documented procedures Are calibrations traceable to NIST ( in the United States) Is the equipment labeled Is non-calibrated equipment isolated Are personnel trained Are the reference standard calibration certificates available Are R&R studies available

QUESTIONS INTERNAL AUDITS Is there a procedure Is there a schedule Have the scheduled audits been performed and are there reports Are the audits conducted by trained personnel Have the non-conformances been investigated

QUESTIONS COMPLAINTS Is there a procedure to record and investigate complaints Are complaints applicable to other products Who are members of the investigating teams

QUESTIONS INSPECTIONS Is there procedures for incoming, in-process and final products Is the data recorded, maintain and trends reviewed Are there control plans for each product What sampling plan is used, AQL’s Are there calculated CpK’s for each product Are control charts available for key measurements Is there a process flow chart available for each process Is there a preventative maintenance program

QUESTIONS TRAINING Are employees trained for their specific jobs Are records maintained and by whom Who conducts the training Are there job descriptions Is there new employee training Is there evidence of periodic personnel reviews

QUESTIONS CAPA Is there a procedure to collect, record, investigate and report findings Are root causes investigated Has preventive action been taken. Have investigations been done to determine effectiveness of the CAPAs implemented Are findings investigated for similar processes or products Are non-conforming products identified and segregated. Who are members of the CAPA team investigations

QUESTIONS DOCUMENT AND RECORDS CONTROL Are there procedures to prepare, review and distribute new documents Are there procedures to remove obsolete procedures. How are procedures made available to those that need to use them How are employees made aware of what is the current revision How are records stored and protected from deterioration

QUESTIONS DESIGN CONTROLS Are design reviews conducted and by whom How are customers needs determined How are customers needs turned into requirements (specifications} Is there a procedure for design changes and modifications Who reviews and approves the changes

QUESTIONS PURCHASING CONTROLS Is there an approved provider list How are responsible personnel (providers, qc, production) made aware of spec changes. Who are members of the provider audit teams Are providers issued report cards Do contracts contain a statement that the customer can audit the provider  

COMPLETING the Audit All observations (findings) should be: - Documented - Reviewed - Clear and Concise - Supported by evidence - Acknowledged by the auditee

THAT’S ALL FOLKS Biguy25103@aol.com